The Post-operative Effect on Formation of Oedema After Total Knee Arthroplasty With or Without the Use of a Nerve Stimulator (the gekoTM Device)

NCT05042492 | Unknown

• 1 other identifier: MMS.2020.058
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate whether the recovery of muscle function of total knee arthroplasty is accelerated with the use of the gekoTM device along with its effect on reducing symptoms such as oedema and inhibition of the muscle function.

Conditions

Osteoarthritis, Knee; Edema Leg; Joint Diseases; Rehabilitation

Keywords

Total Knee Arthroplasty; Osteoarthritis; Arthritis; Edema; Patient reported outcomes (PROMs); Telerehabilitation; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• The primary objective of the study is to assess the post-operative effect of gekoTM on formation of oedema following Total Knee Arthroplasty (TKA)

  This is measured by the use of a perometer. For each patient, change in limb volume shall be calculated as a percentage of original limb volume. Shapiro-Wilk test shall be used to test whether there is a significant (p\<0.05) departure from normal distribution in either group.

  until end of rehabilitation (+- 3 months after TKA operation)

Secondary Outcomes (21)

• Incidence of Adverse Events

  until end of rehabilitation (+- 3 months after TKA operation)

• Incidence of Device Deficiency

  during 10 days after TKA operation

• Oedema measurements - subjective slider

  until end of rehabilitation (+- 3 months after TKA operation)

• Oedema measurements - photographic evaluation

  until end of rehabilitation (+- 3 months after TKA operation)

• Patient Reported Outcome Measures (PROM's)

  2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation)

Study Arms (2)

Group 1: SC (moveUP)

NO INTERVENTION

In group 1: moveUP (class 1, CE-marked, medical device) is being used as the rehabilitation solution after TKA. It has become a valid digital rehabilitation solution and is recognised by the Belgian government as mobile health application in rehabilitation of hip and knee arthroplasty surgeries. It's a full service with daily personalized and individualized follow up by certified physical therapists and certified health care providers. The use of tele-rehabilitation for TKA patients has been internationally recognized with the 2018 John N. Insall Award during the American Knee Society Meeting

Group 2: SC (moveUP) with 10 days of geko

EXPERIMENTAL

In group 2: Next to SC (moveUP), the application of a single gekoTM device is used on the operated leg after surgery (day 0). This device will be worn for 24 hours and at least 8 hours from day 1 until day 10.

Device: gekoTM

Interventions

gekoTM DEVICE

The gekoTM device is a small, transcutaneous nerve stimulator that is placed non-invasively on the skin, whereby the surface electrodes will be attached close to the peroneal nerve. Activation of the peroneal nerve causes contraction of the calf muscle pump, which will increase blood circulation that corresponds to 60% of walking. The increased blood circulation reduces the pressure difference between capillaries and the surrounding tissue and transfers the tissue fluid back into the veins and lymph fibers

Group 2: SC (moveUP) with 10 days of geko

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary TKA planned for degenerative OA
• Subjects must be discharged to home environment and be able to independently perform the activities of daily life
• Obtain a written informed consent

You may not qualify if:

• TED stockings, Dauerbinde, other compressive bandages
• Mechanical foot pump
• Cooling device type 'Game Ready'
• Posttraumatic OA of the knee
• History of DVT / Flebitis / Pulmonary embolism
• Surgical treatment of venous insufficiency \<1y prior to TKA surgery
• Neurological deficit of lower limbs
• Current sciatic irradiating pain in lower limbs
• History of lumbar fusion
• Knee Arthroscopy of the involved limb \<6m prior to TKA surgery
• Any per-operative complication related to the TKA procedure (bleeding, fracture, vascular injury, cardiac complication, pulmonary complication)
• In case of a release during the TKA procedure
• Any per-operative (e.g. epidural catheter, urethral catheter, intra articular catheter) or post-operative procedure that might interfere with the rehabilitation during and after hospitalization
• Any scheduled surgery in the 3 months following the reference surgery;
• Any significant medical condition (e.g. Parkinson's disease, multiple sclerosis, cerebral vascular accident) that might interfere with the rehabilitation

Sponsors & Collaborators

• moveUP bv: lead
• Firstkind Ltd: collaborator

Study Sites (1)

AZ maria middelares

Ghent, East-Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Joint Diseases; Osteoarthritis; Arthritis; Edema

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Van Overschelde

  Algemeen Ziekenhuis Maria Middelares

  STUDY DIRECTOR

Central Study Contacts

Ward Servaes

CONTACT

+32 800 88 008; support@moveup.care

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study was designed as a single centre, prospective, randomised (1:1), dual arm, single treatment, unblinded, interventional study that will be performed on patients undergoing unilateral TKA for primary OsteoArthritis.

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: September 13, 2021
• Study Start: January 14, 2021
• Primary Completion: July 1, 2023
• Study Completion: November 1, 2023
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

BE (1)